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Clinical Trial NCT00726440 for Type 1 Diabetes is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Are the Continuous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients? 180 Randomized
Clinical Trial NCT00726440 was an interventional study for Type 1 Diabetes that is now completed. The study started on 1 February 2008, with plans to enroll 180 participants. Led by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète, the expected completion date was 1 June 2010. The latest data from ClinicalTrials.gov was last updated on 9 February 2012.
Brief Summary
The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.
Detailed Description
The primary objective of the study is to determine whether patients with chronically poor glycaemic control as evidenced by HbA1c >= 8% twice can achieve improved metabolic control using during one year CGM together with educative program about insulin adaptation doses compared to conventional self monitoring finger sticks with educative program about insulin adaptation doses alone.
Official Title
Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?
Conditions
Type 1 DiabetesPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2007-A01022-51
NCT ID Number
Start Date (Actual)
2008-02
Last Update Posted
2012-02-09
Completion Date (Estimated)
2010-06
Enrollment (Estimated)
180
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Type 1 Diabetes
Real Time Continuous Glucose Monitoring System
HbA1c
Navigator®
Real Time Continuous Glucose Monitoring System
HbA1c
Navigator®
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGroup1-patient The patient will be encouraged to use the Navigator® all the time and to modify his treatment according to the continous blood glucose measurements. The patients will follow an educational process in order to adapt insulin doses according to each sensor data. | Navigator® Patients will be encouraged to use the Navigator® all the time and to modify their treatment according to the device measurments. Patients will also follow and educational process in order to adapt insulin doses according to each sensor data |
Active ComparatorGroup2-diabetologist The patient will follow the same educational process as group 1 concerning insulin dose adaptation. They will use the continous glucose monitoring device according to the diabetologist's prescription and they will receive precise instructions to make considering results. The duration of the use of the Navigator® will be increased if one of the following criteria is observed at the consultation each 3 months:
* HbA1c...Show More | Navigator® Patients will follow the same educational process as group1 concerning insulin doses adaptation.The duration of the use of the devicewill be determined at the consultation every each 3 months. |
Placebo ComparatorGroup3-Control Usual follow up with self-monitoring blood glucose. | Placebo Patients will have their usual follow up with self-monitoring blood glucose |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Comparison of HbA1c mean between the 3 groups | at 1 year |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Comparison of glucose stability in the 3 groups | inclusion, M3, M6, M9, M12 | |
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period | study period | |
Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12 | prior to inclusion and prior to M3, M6, M9, M12 | |
Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection | inclusion, M3, M6, M9, M12 | |
Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups | inclusion and M12 | |
Comparison of weight, insulin doses, in each group | study period | |
comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption | study period |
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
8 Years
Eligible Sexes
All
- Type 1 Diabetes for ≥ 12 months or more (including Cpeptide negative secondary diabetes)
- Children between 8 and 18 years old
- Adults between 18 and 60 years old
- Patients treated with basal-bolus insulin regimens, pump or multiple daily injection, only with analogs, for at least 6 months
- Performing at least 2 finger sticks glucose controls per day
- Able and motivated to use the device
- HbA1c ≥ 8% twice with HPLC method(DCA 2000 excluded)
- Written informed consent obtained prior to enrollment in the study
- Blindness or impaired vision so the screen cannot be recognized
- Allergy to sensor
- Active proliferative retinopathy not stabilized by laser or vitrectomy occurence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during study
- Treatment with systemic corticosteroid or medication known to influence insulin sensitivity in the 3 months prioir to visit 1
- Pregnancy
- Manifest psychiatric disturbance
- Presence of any conditions (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actuel or anticipated that the investigators feels would compromise the patient safety or limit his/her successful participation in the study.
- Hemoglobinopathy that interfers with HbA1c measurement
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteNo contact data.
19 Study Locations in 2 Countries
CHU Sart Tilman Liège, Liège, 4000, Belgium
Besancon
CHU Jean Minjoz, Besançon, Besancon, 25030, France
Corbeil Essonnes
CH SUD Francilien, Corbeil-Essonnes, Corbeil Essonnes, 91100, France
Grenoble
University Hospital Grenoble, Grenoble, Grenoble, 38043, France
Lyon
Hopital Edouard Herriot, Lyon, Lyon, 69003, France
Marseille
CHU Marseille Hôpitaux Sud, Marseille, Marseille, 13274, France
Montpellier
Chu Montpellier, Montpellier, Montpellier, 34295, France
Nancy
CHU Hôpital Jeanne d'Arc, Nancy, Nancy, 54201, France
Nantes
CHU Nantes, Nantes, Nantes, 44093, France
Paris
Hopital Hotel Dieu, Paris, Paris, 75004, France
Pessac
Hopital Haut Leveque, Pessac, Pessac, 33604, France
Rennes
CHU Rennes, Rennes, Rennes, 35056, France
Saint Etienne
Hopital Bellevue, Saint-Etienne, Saint Etienne, 42055, France
Toulouse
CHU Toulouse, Toulouse, Toulouse, 31403, France
CHU La Pitié Salpetrière, Paris, 75013, France
CHU Robert Debré, Paris, 75019, France
CHU de Reims-Hôpital Américain, Reims, 51100, France
CHU de Reims-Hôpital Robert debré, Reims, 51100, France
CHU Strasbourg, Strasbourg, 67091, France